FDA Adverse Event
Injury
Summary report: N
THOPAZ+ DRAINAGE SYSTEM LOAN 1CT PT-A 19
MDR report key: 23014949
·
Received September 10, 2025
Report
- Report Number
- 1419937-2025-00025
- Event Type
- Injury
- Date Received
- September 10, 2025
- Date of Event
- August 18, 2025
- Report Date
- September 10, 2025
- Manufacturer
- MEDELA AG
- Product Code
- BTA
- UDI-DI
- 07612367041027
- PMA / PMN Number
- K130210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE MEDELA THOPAZ+ PUMP WAS REMOVED FROM THE PATIENT DUE TO AN ERROR MESSAGE AND WAS REPLACED WITH A COMPETITOR'S PUMP. ON 9/4/25 THE THOPAZ+ WAS DELIVERED TO MEDELA LLC AND WAS EVALUATED ON (B)(6) 2025. THE DEVICE WAS RUN FOR ONE HOUR AND NO ERROR MESSAGES OCCURRED. THE LOG FILE SHOWED RECENT ERRORS BUT COULD NOT BE REPRODUCED. THE DEVICE PASSED TESTING.
Description of Event or Problem · 0
ON (B)(6) 2025, A FACILITY CONTACTED MEDELA LLC AND ALLEGED THAT WHILE USING A THOPAZ+ PUMP AN INTERNAL ERROR MESSAGE OCCURRED. IT IS UNDETERMINED THE LENGTH OF TIME THE ERROR MESSAGE WAS ON UNTIL DISCOVERED BY THE TREATING SURGEON IN THE MORNING. THE PATIENT DEVELOPED PNEUMOTHORAX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2176404 | THOPAZ+ DRAINAGE SYSTEM LOAN 1CT PT-A 19 | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) | BTA | MEDELA AG | 101029471 | 0000731758 | 07612367041027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |